Feasibility of a Goal-based Agenda Setting Intervention

November 23, 2021 updated by: Glyn Jones-Elwyn, Dartmouth-Hitchcock Medical Center

Feasibility of a Goal-based Agenda Setting Intervention for Informing Conversations in Adult Cystic Fibrosis Care

This study aims to assess the feasibility of a new, brief intervention, the 'coopeRATE Prompt', for informing conversations between patients and physicians in routine tele-health and in-person adult Cystic Fibrosis (CF) care. The coopeRATE Prompt is two questions designed to elicit patients' concerns and goals to facilitate collaborative goal setting within the health care visit. This is a prospective single arm study that will be conducted at four CF care centers in the United States.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participating patients will be asked to complete two online surveys. The first survey, which includes the coopeRATE Prompt intervention questions, is completed 1-4 days before their upcoming healthcare visit. After completing this survey and before their visit, patients' intervention responses are shared with their physician and, if requested, other members of their care team. The second patient survey is completed within 24 hours after their healthcare visit. Participating clinicians are asked to complete a single online survey within one month after completion of patient data collection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
219

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have a diagnosis of CF
  • are 18 years of age or older
  • can read and write English
  • have a scheduled in-person or tele-health routine CF care visit
  • have access to internet and email

Exclusion Criteria:

  • does not have a diagnosis of CF
  • is less than 18 years of age
  • cannot read and write English
  • does not have a scheduled in-person or tele-health routine CF care visit
  • does have access to internet and email

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
coopeRATE Prompt
Behavioral: coopeRATE Prompt
The coopeRATE Prompt intervention is a set of two questions delivered to patients before the clinical encounter that elicit their concerns and goals. The intervention is delivered to patients online, outside the clinic setting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Use of intervention responses with physician (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported discussion of intervention responses (concerns and goals) in the visit with physician, assessed using two items with multiple choice (single answer) format. The first item assesses how many of the patient concerns were discussed and the second item assesses how many of the patient goals were discussed. Item response options are 'None of them', 'Some of them', or 'All of them'.
Within 24 hours after completion of the healthcare visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intervention completion (patient-reported)
Time Frame: 1-4 days before the healthcare visit
Presence of a response to each of the coopeRATE Prompt intervention questions. The coopeRATE Prompt includes two items with open-text response format.
1-4 days before the healthcare visit
Intervention acceptability (patient-reported)
Time Frame: 1-4 days before the healthcare visit
Patient-reported intervention acceptability, assessed using an adapted version of the 4-item Acceptability of Intervention Measure (Weiner et al., 2017). Each item is rated on a 5-point scale ranging from 1 ('Completely disagree') to 5 ('Completely agree'). A respondent's total score is the mean of all item responses.
1-4 days before the healthcare visit
Utility of intervention (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported utility (helpfulness) of intervention, assessed using a single adapted item (Dalcin et al., 2015). The item is rated on a 5-point scale ranging from 0 ('Not at all helpful') to 4 ('Extremely helpful').
Within 24 hours after completion of the healthcare visit
Way(s) in which intervention was helpful (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format.
Within 24 hours after completion of the healthcare visit
Initiator of discussion (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported initiator of discussion of intervention responses in the visit with physician, assessed using a single item with multiple choice (single answer) format.
Within 24 hours after completion of the healthcare visit
Satisfaction with time spent (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported satisfaction with amount of time spent discussing intervention responses in the visit with physician, assessed using a single item with multiple choice (single answer) format.
Within 24 hours after completion of the healthcare visit
Preference for sharing intervention responses with other team members (patient-reported)
Time Frame: 1-4 days before the healthcare visit
Patient-reported preference for sharing intervention responses with other members of the care team, assessed using a single item with multiple choice (multiple response) format.
1-4 days before the healthcare visit
Use of intervention responses with other team members (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported discussion of intervention responses in the visit with other members of the care team, assessed using two items. The first item assesses whether intervention responses were discussed, with a multiple choice (single answer) format. The second item assesses the specific team members with whom discussions were had, with a multiple choice (multiple answer) format.
Within 24 hours after completion of the healthcare visit
Satisfaction with intervention timing (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported satisfaction with timing of intervention delivery, assessed using a single item with multiple choice (single answer) format.
Within 24 hours after completion of the healthcare visit
Preferred intervention timing (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported preferred timing of intervention delivery, assessed using a single item with open-text response format.
Within 24 hours after completion of the healthcare visit
Future receipt of intervention (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported preference for receiving the intervention again in the future, assessed using a single item with multiple choice (single answer) format.
Within 24 hours after completion of the healthcare visit
Collaborative goal setting (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
A new 3-item patient-reported measure under evaluation to assess collaborative goal setting between a patient and physician during the health care visit. Each item is rated on a 4-point scale ranging from 0 ('Strongly disagree') to 3 ('Strongly agree'), with an additional 'Not sure' option. Scoring method is to be determined.
Within 24 hours after completion of the healthcare visit
Shared decision-making (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported shared decision-making with physician during the health care visit, assessed using the 3-item collaboRATE measure (Elwyn et al., 2013; Barr et al., 2014). Each item is rated on a 10-point scale ranging from 0 ('No effort was made') to 9 ('Every effort was made'). Respondent's are assigned a score of 1 if every item is rated 'Every effort was made' and a score of 0 for all other response combinations.
Within 24 hours after completion of the healthcare visit
Frequency of intervention receipt (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported frequency of receiving patient intervention responses, assessed using a single item with open-text response format.
Within 1 month following completion of patient data collection
Use of intervention responses with patients (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported frequency of use of intervention responses with patients in the visit, assessed using a single item with multiple choice (single answer) format.
Within 1 month following completion of patient data collection
Utility of intervention (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported utility (helpfulness) of intervention, assessed using a single adapted item (Dalcin et al., 2015). The item is rated on a 5-point scale ranging from 0 ('Not at all helpful') to 4 ('Extremely helpful').
Within 1 month following completion of patient data collection
Way(s) in which intervention was helpful (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format.
Within 1 month following completion of patient data collection
Impact on time spent with patients (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported impact on amount of time spent with patients, assessed using a single item with multiple choice (single answer) format.
Within 1 month following completion of patient data collection
Reason(s) for not using intervention (never used) (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported reason(s) for never discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format.
Within 1 month following completion of patient data collection
Reason(s) for not using intervention (sometimes used) (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported reason(s) for only sometimes discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format.
Within 1 month following completion of patient data collection
Intervention acceptability (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported intervention acceptability, assessed using an adapted version of the 4-item Acceptability of Intervention Measure (Weiner et al., 2017). Each item is rated on a 5-point scale ranging from 1 ('Completely disagree') to 5 ('Completely agree'). A respondent's total score is the mean of all item responses.
Within 1 month following completion of patient data collection
Future use of intervention (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported preference for using the intervention with patients in the future, assessed using a single item with multiple choice (single answer) format.
Within 1 month following completion of patient data collection

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concerns and goals (patient-reported)
Time Frame: 1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
Patient-reported concerns and goals, assessed using the coopeRATE Prompt intervention. The coopeRATE Prompt includes two items with open-text response format. Item responses are assessed in terms of concern and goal frequency and type (categorizations to be determined).
1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
Additional intervention feedback (patient-reported)
Time Frame: 1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
Patient-reported additional intervention feedback, assessed using two items with open-text response format. Additional feedback is first assessed immediately after completing the intervention questions and again after the index healthcare visit.
1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
Type of routine healthcare visit (patient-reported)
Time Frame: Within 1 month following completion of patient data collection
Patient-reported type of routine CF care visit (e.g., in-person only, phone-only), assessed using a single item with multiple choice (single answer) format.
Within 1 month following completion of patient data collection
People seen during the visit (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported people seen (e.g., doctor, nurse) during the healthcare visit, assessed using a single item with multiple choice (multiple answer) format.
Within 24 hours after completion of the healthcare visit
History with people seen during the visit (patient-reported)
Time Frame: Within 24 hours after completion of the healthcare visit
Patient-reported history with people seen during the healthcare visit, assessed using a single item with multiple choice (single answer) format.
Within 24 hours after completion of the healthcare visit
Additional intervention feedback (clinician-reported)
Time Frame: Within 1 month following completion of patient data collection
Clinician-reported additional intervention feedback, assessed using a single item with open-text response format.
Within 1 month following completion of patient data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cystic Fibrosis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00047666 (Other Identifier: DUHS IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified copy of participant-level data and essential analytic code will be made available to others for research purposes, via data sharing.

IPD Sharing Time Frame

The data and supporting information will be available after December 2021 and for an indefinite period of time.

IPD Sharing Access Criteria

Requests must include sufficient justification for the data which does not duplicate any current or planned data use. All requests will be subject to Investigator approval.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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